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Avandia starting to sound a lot like Vioxx
Mark D. is fighting for justice on behalf of his brother, Grant, whose health has gone downhill since he was prescribed Avandia.
News for 2007
Avandia heart attacks seen in general patient population
The consequences of deadly Avandia side-effects are now being seen in the general population, a new study has found. Previously, evidence that Avandia placed patients at an increased risk of heart attacks had only been seen in clinical trials. But now, Canadian researchers have found that patients taking the controversial diabetes drug who are not enrolled in clinical trials are showing increased evidence of heart attacks and other cardiac problems.
Avandia risks highlighted
Canadian researchers furnished the strongest evidence to date linking the popular diabetes drug Avandia to an increased risk of heart attack in a scientific study released yesterday.
New Avandia study reaffirms heart risk
Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians out Wednesday.
Diabetes drug Avandia could weaken bones
Two U.S. healthcare providers drop Glaxo’s Avandia
Two U.S. pharmacy benefit managers said on Thursday they had dropped GlaxoSmithKline Plc’s (GSK.L: Quote, Profile, Research) diabetes drug Avandia from their national formularies due to safety concerns.
Avandia now linked to Osteoporosis
GlaxoSmithKline, the manufacturer of Avandia, has already admitted that Avandia does contribute to bone fractures in women. However, the latest research goes further in understanding the issue, just what is happening to those brittle bones, and what it is that’s making them brittle in the first place.
Diabetes drug may increase bone thinning
The popular diabetes drug marketed as Avandia may increase bone thinning, a discovery that could help explain why diabetics can have an increased risk of fractures.
Avandia heart attack controversy results in black box warning
Avandia, a drug used in the treatment of type 2 diabetes, has been at the center of controversy since being linked to an increased risk of heart attack last May. An update to the black box warning-today’s strongest drug warning-is now being added to the Avandia label.
The U.S. Food and Drug Administration (FDA) advised that GlaxoSmithKline, Avandia’s maker, agreed to add the new warning to the existing black box warning. But, despite the revision, the FDA will not withdraw Avandia from the market, claiming that evidence for increased heart attack is inconclusive and does not appear to be higher in Avandia than other type 2 diabetes treatments. In the meantime, the FDA asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will likely commence in a year; however, full results will not be available until 2014. Patient advocates and FDA critics consider the black box warning a weak response to Avandia’s safety issues and have requested Avandia be pulled from the market.
Avandia breaks down the body’s resistance to insulin but has long been known to cause fluid retention, a major risk factor for congestive heart failure. Evidence does not indicate Avandia and other oral anti-diabetes drugs-thiazolidinediones-prevent cardiovascular risk as a result of reducing blood sugar.
The American Diabetes Association and the European Association for the Study of Diabetes released a revised consensus statement stating that emerging information suggests additional hazards associated with thiazolidedione and rosiglitazone (Avandia) and may result in increased risk of myocardial infarctions. In October, the US Department of Veterans Affairs (VA) announced it was dropping Avandia from its prescription drug formulary stating their review concluded that, in some, Avandia did not afford the same margin of safety as other diabetes medications. The VA accounted for nearly 10-percent of Avandia’s US sales.
In November, Health Canada sent a letter to Canadian health professionals advising Avandia could no longer be prescribed as monotherapy for type 2 diabetes or in combination with sulfonylurea. In May, research based on 42 Avandia studies confirmed a 43-percent increased risk of heart attack among patients taking the drug. In August, Avandia’s warning label was changed to warn that Avandia and others in its class might worsen heart failure.
A Congressional Committee Report found that company executives made a concerted effort to intimidate a diabetes expert into keeping quiet about Avandia’s safety problems, alleging that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved. An internal government memo dated July 16, 2002 analyzed 47 early FDA reports of patients who went into heart failure and required hospitalization while taking Avandia. The report contained warnings from Federal investigators that Avandia might cause heart failure.
Over six million Americans have used the drug to treat adult-onset, or type 2, diabetes and the concern about Avandia is nothing new. The association between Avandia and increased heart failure risk has been known since 1999 when the drug was first approved.
Avandia was Glaxo’s second most popular drug in 2006, with sales of $3.3 billion. Sales have plummeted since publication of evidence linking Avandia with increased risk of heart attack and failure.
November 29th, 2007 by Staff with NewsInferno.com
Avandia side effects prompt new caution from American Diabetes Association
Risks associated with Avandia have led the American Diabetes Association to call on doctors to use more caution when prescribing oral medications to treat people with type two diabetes.
